Positive Airway Pressure (PAP) System Evaluation in Volunteers

NCT ID: NCT07246538

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-06-30

Brief Summary

This study will test the control and measurements of a new system for airway support in healthy volunteers. The goals of the study are to evaluate how accurately the system can stabilize airway pressure to a desired level, evaluate the accuracy of the system's reported volume of each breath (tidal volume), evaluate the accuracy of the system's reported respiratory rate, evaluate the accuracy of exhaled carbon dioxide monitoring with a standard carbon dioxide monitor when the novel PAP system is used, and evaluate general comfort of the volunteers while using the system.

Detailed Description

Sedation procedures involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A common side effect of these drugs is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. Research has shown that this risk can be effectively reduced by administering PAP therapy during sedation, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth. However, non-invasive ventilators used for administering PAP therapy are expensive and large, and often not available in areas of the hospital where sedation procedures take place.

The investigators have developed a small and low-cost novel PAP system for use in sedation procedures that controls airway pressure to desired levels (a feature that is generally only available in larger and higher-cost devices), provides estimates for tidal volumes (generally only available with a non-invasive ventilator), provides respiratory rate estimates, and allows for more accurate monitoring of exhaled carbon dioxide with a standard carbon dioxide monitor using a novel approach that to the investigator's knowledge has not been published. The goal of investigator's study is to demonstrate the accuracy of these features in human subjects. The system is much smaller and less expensive than a non-invasive ventilator, provides enhanced respiratory monitoring, and has the potential to be a practical alternative that would make PAP therapy during sedation much more feasible.

The investigator's evaluation will primarily include evaluating the investigator's system's performance against an FDA cleared commercial respiratory monitor to verify accuracy. The investigators anticipate that the investigator's system will automatically adjust oxygen flow to maintain a desired airway pressure even in the presence of variables such as mask leak and patient inhalation flow. The investigators also anticipate that the investigator's system will provide tidal volume estimates within 15% of the respiratory monitor reference measurement, as well as respiratory rate estimates that closely match the respiratory monitor. The investigator's system employs a method that detects when the patient exhales and removes mask pressure during exhalation, and the investigators anticipate that this will result in improved comfort for the patient, as well as improved carbon dioxide monitoring accuracy, since removing flow during exhalation reduces dilution of the expired gas sample that is used for measuring exhaled carbon dioxide levels.

Conditions

Obstruction Airway

Keywords

Device feasibility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

CPAP

Airway pressure support through the investigational device

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Airway pressure support through the investigational device.

Interventions

CPAP

Airway pressure support through the investigational device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Have any respiratory or cardiovascular conditions
• i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dynasthetics LLC

UNKNOWN

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Kuck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Central Contacts

Kai Kuck, PhD

Role: CONTACT

Phone: (801) 581-6393

Email: kai.kuck@hsc.utah.edu

Trey Blackwell, MS

Role: CONTACT

Phone: (801) 395-4038

Email: Trey.Blackwell@utah.edu

References

Burk KM, Sakata DJ, Kuck K, Orr JA. Comparing Nasal End-Tidal Carbon Dioxide Measurement Variation and Agreement While Delivering Pulsed and Continuous Flow Oxygen in Volunteers and Patients. Anesth Analg. 2020 Mar;130(3):715-724. doi: 10.1213/ANE.0000000000004004.

Reference Type: BACKGROUND

PMID: 30633057 (View on PubMed)

Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.

Reference Type: BACKGROUND

PMID: 31760586 (View on PubMed)

Other Identifiers

IRB_00190165

Identifier Type: -

Identifier Source: org_study_id